Global Regulatory CMC Director: Strategy & Submissions

BioSpace; Indianapolis (IN); Hybrid; USD 149,000 - 257,000; Full time

Benefits offered by this job

Relocation assistance

Remote option possible

Minimal travel

Job summary

Lilly, headquartered in Indianapolis, IN, invites a seasoned Regulatory CMC leader to join our global team. You will shape regulatory strategy across small molecule development, supply chain, and lifecycle submissions, with emphasis on regulatory precedent and global guidelines.

In this role, you will guide CMC teams, author and review submissions, and coordinate interactions with health authorities. A remote option may be considered; relocation assistance is provided for ideal candidates.

Qualifications

• B.S. degree in science, engineering, or STEM field (advanced degree preferred).
• 10+ years of Regulatory CMC experience supporting clinical development or commercialization of synthetic molecules.
• Experience authoring CMC submissions and guiding regulatory interactions.

Responsibilities

• Provide regulatory leadership across CMC to expedite development and registrations.
• Lead preparation, review, and approval of CMC documents for global submissions.
• Develop and implement regulatory strategies aligned with global guidelines.
• Guide CMC development teams on lifecycle planning and risk management.
• Support Health Authority meetings and cross-geography alignment.

Skills

Regulatory CMC leadership

Regulatory strategy

Leadership

Regulatory guidance

Strong written and verbal skills

Education

Bachelor's degree in science/engineering/ STEM

Advanced degree preferred

Job description

Lilly, headquartered in Indianapolis, IN, invites a seasoned Regulatory CMC leader to join our global team. You will shape regulatory strategy across small molecule development, supply chain, and lifecycle submissions, with emphasis on regulatory precedent and global guidelines.

In this role, you will guide CMC teams, author and review submissions, and coordinate interactions with health authorities. A remote option may be considered; relocation assistance is provided for ideal candidates.